Carl Zeiss Meditec Cataract Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K243395 | MICOR 700 with Auto I/A | August 8, 2025 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrec | June 11, 2025 |
| K214028 | MICOR Lens Fragmentation System | September 9, 2022 |
| K222236 | miCOR System Lens Fragmentation System | August 24, 2022 |
| K200207 | xPORT S Lens Fragmentation System | October 15, 2020 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | July 31, 2020 |
| K191024 | xPORT Lens Fragmentation System | August 13, 2019 |